BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HWA TEH EXAMINATION GLOVES

    K Number: K896251 · Decision Nov 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    22

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    Basic Information

    Device Name
    HWA TEH EXAMINATION GLOVES
    K Number
    K896251
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Hwa Teh Industrial Sdn. Bhd.
    Date Received
    October 30, 1989
    Decision Date
    November 21, 1989
    Product Code
    LYY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYY Latex Patient Examination Glove

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    Other Clearances by Hwa Teh Industrial Sdn. Bhd.

    K Number Device Name
    K010803 POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
    K000725 HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
    K994432 HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
    K992810 HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
    K992730 HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE